Job Description

Job Title: QA Officer - Pharma (Only W2, No C2C)

Location: Rockville, MD

Duration : 12 Months (Only W2, No C2C)

Industry : Core Pharma

Job Description:

We are currently seeking a QA Officer for a long-term contract role in Rockville, MD with a leading pharmaceutical manufacturer. The ideal candidate will be responsible for ensuring compliance with regulatory and quality standards by supporting Quality Assurance operations, particularly in batch record review , SOP adherence , and QMS activities .

Key Responsibilities:

• Perform review and approval of batch manufacturing and packaging records to ensure compliance with cGMP standards.
• Participate in the initiation and review of SOPs , ensuring documents are updated and followed correctly.
• Manage Quality Management System (QMS) activities including Deviations, CAPA (Corrective and Preventive Actions), and Change Control processes.
• Collaborate with cross-functional teams (Production, QC, Regulatory) to address quality issues and support continuous improvement initiatives.
• Monitor GMP compliance across the site, providing training and guidance to ensure adherence to quality practices.
• Conduct audits and assessments related to QMS effectiveness and provide feedback for improvement.
• Assist in regulatory inspections and internal audits as needed.

Qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related field.
• Minimum 2–4 years of experience in pharmaceutical QA, particularly in a batch review and documentation-heavy environment .
• Strong understanding of FDA regulations , ICH guidelines , and cGMP standards .
• Hands-on experience in handling Deviations, CAPA, Change Control , and working within a QMS .
• Excellent attention to detail, communication, and organizational skills.

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